Tuna 74269
GUDID 00816879021325
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent| Primary Device ID | 00816879021325 |
| NIH Device Record Key | 03d10967-6c64-4c1b-9660-6698273893b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tuna |
| Version Model Number | F040 |
| Catalog Number | 74269 |
| Company DUNS | 010558476 |
| Company Name | HYCOR BIOMEDICAL LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816879021325 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K830817
FDA Product Code
| DGC | Ige, Antigen, Antiserum, Control |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-26 |
Devices Manufactured by HYCOR BIOMEDICAL LLC
Trademark Results [Tuna]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TUNA 90195631 not registered Live/Pending |
Ding, Chentao 2020-09-21 |
 TUNA 90001337 not registered Live/Pending |
Atlantic Diamond Tools, Inc. 2020-06-15 |
 TUNA 87378609 not registered Dead/Abandoned |
TUNA INTERNATIONAL LTD. 2017-03-21 |
 TUNA 86841378 5157367 Live/Registered |
GMB Partners LLC 2015-12-07 |
 TUNA 79384946 not registered Live/Pending |
Zhejiang TUNA Environmental Science & Technology Co., Ltd. 2023-09-06 |
 TUNA 79382951 not registered Live/Pending |
Zhejiang TUNA Environmental Science & Technology Co., Ltd. 2023-09-06 |
 TUNA 79373555 not registered Live/Pending |
Murat Yetis 2023-05-05 |
TUNA 79373555 not registered Live/Pending |
Halil Ibrahim Yetis 2023-05-05 |
 TUNA 78775437 not registered Dead/Abandoned |
FORTUNA BAY HOLDINGS LIMITED 2005-12-16 |
 TUNA 77919920 3976437 Live/Registered |
Nanjing Fire Protection Technology Co.,Ltd 2010-01-26 |
 TUNA 76351564 2654175 Dead/Cancelled |
HedgeFund.net, Inc. 2001-12-21 |
 TUNA 76120752 2506178 Dead/Cancelled |
Milky Way International Trading Corporation 2000-08-31 |
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